Muscular AtrophyNCT02817646
Study in ICU Patients Regarding Protein Intake and CT-derived Body Composition
An observational study of Muscular Atrophy, run by Amsterdam UMC, location VUmc.
Trial summary
The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- Computed tomography scan made for clinical reasons and Nutrition as per hospital protocol
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the intensive care unit
Who may be able to join
- Abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit
- Length of intensive care stay of at least 4 days
- Mechanical ventilation during intensive care stay
Who cannot join
- Computed tomography scan not eligible for analysis
- Missing data
About this study
Official title: A Retrospective Investigator Initiated Trial Evaluating Protein Intake and CT Assessments of Muscle Mass of Critically Ill Patients in Relation to Outcome Parameters: the PROMUS-study
The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.
Read the detailed description
Optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. However, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. Computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass.
The investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. This is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. Therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass.
Additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. Finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.
- Conditions
- Muscular Atrophy
- Being tested
- Computed tomography scan made for clinical reasons, Nutrition as per hospital protocol
- Keywords
- Intensive Care Unit, Critical Illness, Body composition, Protein nutrition
- Medical subject headings
- Muscular Atrophy, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography scan made for clinical reasonsOther
Patients were included if a computed tomography scan of the abdomen or thorax was made early during intensive care admission (1 day before up to 4 days after admission)
Nutrition as per hospital protocolDietary supplement
Patients received enteral and/or parenteral nutrition as per usual hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| Intensive care patients | Patients admitted to the intensive care unit for 4 days or more with a computed tomography scan made for clinical reasons early during intensive care stay and who receive enteral and/or parenteral nutrition as per hospital protocol Receives: Other: Computed tomography scan made for clinical reasons; Dietary Supplement: Nutrition as per hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 6-months after intensive care admission
All-cause mortality
Measured: 28-days after intensive care admission
All-cause mortality
Measured: 60-days after intensive care admission
All-cause mortality
Measured: 90-days after intensive care admission
All-cause mortality
Measured: From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks
All-cause mortality
Measured: From admission to the intensive care unit untill discharge from the hospital, an average of one month
Secondary outcomes (4)
Percentage of patients discharged to home
Measured: After discharge from the hospital, on average after one month
Length of hospital stay (days)
Measured: The total duration of admission to the hospital, an average of one month
Length of intensive care unit stay
Measured: The total duration of admission to the intensive care unit, an average of two weeks
Length of ventilation
Measured: The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilhelmus G.P.M. Looijaard, MD, Amsterdam UMC, location VUmc
- Investigators
- Peter J. Weijs, PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817646
- Sponsor's protocol ID
- ICUPROMUS
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
PubMed 25499096Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.
PubMed 24410863Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Twisk JW, Oudemans-van Straaten HM, Weijs PJ. Skeletal muscle quality as assessed by CT-derived skeletal muscle density is associated with 6-month mortality in mechanically ventilated critically ill patients. Crit Care. 2016 Dec 1;20(1):386. doi: 10.1186/s13054-016-1563-3.
PubMed 27903267
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Investigator Initiated Trial Evaluating Protein Intake and CT Assessments of Muscle Mass of Critically Ill Patients in Relation to Outcome Parameters: the PROMUS-study
- ClinicalTrials.gov ID
- NCT02817646
- Acronym / sponsor ID
- ICUPROMUS
- Conditions
- Muscular Atrophy
- Keywords
- Intensive Care Unit, Critical Illness, Body composition, Protein nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.
Detailed description
Optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. However, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. Computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass.
The investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. This is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. Therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass.
Additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. Finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care patients | – | Other: Computed tomography scan made for clinical reasons, Dietary Supplement: Nutrition as per hospital protocolPatients admitted to the intensive care unit for 4 days or more with a computed tomography scan made for clinical reasons early during intensive care stay and who receive enteral and/or parenteral nutrition as per hospital protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit
Key inclusion criteria (3 listed)
- Abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit
- Length of intensive care stay of at least 4 days
- Mechanical ventilation during intensive care stay
Key exclusion criteria (2 listed)
- Computed tomography scan not eligible for analysis
- Missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography scan made for clinical reasonsPatients were included if a computed tomography scan of the abdomen or thorax was made early during intensive care admission (1 day before up to 4 days after admission) | Other | Intensive care patients |
| Nutrition as per hospital protocolPatients received enteral and/or parenteral nutrition as per usual hospital protocol | Dietary supplement | Intensive care patients |
Primary outcome
All-cause mortality
Time frame: 6-months after intensive care admission
All-cause mortality
Time frame: 28-days after intensive care admission
All-cause mortality
Time frame: 60-days after intensive care admission
All-cause mortality
Time frame: 90-days after intensive care admission
All-cause mortality
Time frame: From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks
All-cause mortality
Time frame: From admission to the intensive care unit untill discharge from the hospital, an average of one month
4 secondary outcomes
Percentage of patients discharged to home
Time frame: After discharge from the hospital, on average after one month
Length of hospital stay (days)
Time frame: The total duration of admission to the hospital, an average of one month
Length of intensive care unit stay
Time frame: The total duration of admission to the intensive care unit, an average of two weeks
Length of ventilation
Time frame: The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 25499096Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
- Results publication: PubMed 24410863Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.
- Results publication: PubMed 27903267Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Twisk JW, Oudemans-van Straaten HM, Weijs PJ. Skeletal muscle quality as assessed by CT-derived skeletal muscle density is associated with 6-month mortality in mechanically ventilated critically ill patients. Crit Care. 2016 Dec 1;20(1):386. doi: 10.1186/s13054-016-1563-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J. Weijs, PhD study director
Amsterdam UMC, location VUmc
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Atrophy, run by Amsterdam UMC, location VUmc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 6-months after intensive care admission). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817646, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.